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NEBRASKA MPJE UPDATED EXAM
QUESTIONS AND ANSWERS 100% VERIFIED.
What legistation was created for the provisions for the fast track review of some NDA submissions to expedite approval of new drugs used to treat life-threatening conditions? - correct answer- Food and Drug Administration (FDA) Modernization Act 1997 What legistation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? - correct answer- FDA modernization act 1997 What act reduced the cose of orphan drugs? - correct answer- Orphan drug act 1983 What act prohibited the adulteration or misbranding of food and drugs? - correct answer- Pure Food and Drug Act 1906 What act required tha active ingredients be placed on the label of a drug's packaging and that drugs couldn't fall below purity levels established by the USP or National Formulary? - correct answer- Pure food and drug act 1906
What amendment defined two categories - legend and OTC - correct answer- Durham-humphrey 1951 What amendment mandated there must be "adequate directions for use" on the manufacturer's label for OTC's - correct answer- Durham-Humphrey 1951 What amendment declared that all new drugs marketed in the U.S. had to be shown to be safe and effective - correct answer- Kefauver-Harris 1962 What act was passed to correct the problem of diversion from the normal distribution channels. Prohibits drug from being re- imported into the U.S. Except by the manufacturer of said drugs.
- correct answer- Prescription Drug Marketing Act 1987 What act requires proper storage of drugs and maintenance of appropriate distribution records? - correct answer- Prescription Drug Marketing Act 1987 What act prohibits sale, purchase, or trade of any drug which was purchased by a public or private hospital or other health
Within how many days should the department be notified that a pharmacy is closing? - correct answer- 30 days prior Within how many days should the department be notified of the disposition/sale of inventory, prescription records, etc due to pharmacy closing? - correct answer- 15 days When shold the department be notified of a change in PIC? - correct answer- Immediately What information is reported under the Parkinson's disease registry - correct answer- Report shall include the name, address, and socical security number of the person for whom the drugs were prescribed and the name and address of the prescribing physician How long must a pharmacy maintain inventory records - correct answer- 5 years Within how many days should a copy of the initial CS inventory, annual inventory, and/or CS inventory take pursuant to change in PIC be forwarded to the Department? - correct answer- Within 30 days after completion
In the event of a pharmacy closing what documents must be returned to the Department - correct answer- Pharmacy license, pharmacy's DEA registration, all unused DEA 222 Forms If CS inventory is transferred to another pharmacy, how long must those transfer records be maintained? - correct answer- 2 years How often does a consult pharmacist have to physically be in the public health clinic? - correct answer- 30 days May a pharmacy intern transfer CS? - correct answer- Yes May a pharmacy intern conduct DUR? - correct answer- Yes May a pharmacy intern oversee technicians? - correct answer- No
Supervision Ratio - correct answer- 2 technicians : 1 RPh 3 interns : 1 RPh 2 technicians and 1 intern : 1 RPh Are interns receiving their experiential training applied to the supervision ratios - correct answer- No May retail pharmacies receive starter packs? - correct answer- Yes, they are not considered samples and are intended for initiation of drug therpy for a patient. Also not labeled as a sample Possession of prescription drug samples by retail pharmacies would be considered ________ ___________ by the FDA. - correct answer- Drug diversion When may institutional pharmacies receive prescription drug samples? - correct answer- Licensed prescriber requested (disposition precisely recorded and stored separately from normal drug stock) If a licensed practitioner provides written requiests for prescription drug samples, for how long must the manufacturer
keep the request and who is responsible for the annual inventory of the samples? - correct answer- 3 years; sales representatives are responsible for prescription drug samples, including the annual inventory What is proper refrigeration temperatures - correct answer- 36 to 46'F or 2 to 8'C What is the proper freezer temperatures - correct answer- -4 to 14'F or -20 to -10'C What is the proper room temperature? - correct answer- 46 to 59'F or 8 to 15'C A pharmacy must register as a wholesale drug distributor if it distributes more than: - correct answer- 5% gross dollar value of the total prescription drug sales revenue in a 12month period Define long-term detox treatment - correct answer- 30 to 180 days
May a midwife (APRN-CNM) prescribe C2's? - correct answer- Only for up to 72 hours for pain only When is the name of the prescriber (supervisor of PA) required to be on the label of a prescription written by a Physician's Assistant? - correct answer- When required for reimbursement purposes How can a pharmacist verify a prescriber is allowed to prescribe suboxone? - correct answer- Confirm prescriber has been granted a waiver via SAMHSA website/phone, Check DEA# for leading letter "X" What part of an RX may a pharmacist never change? - correct answer- Patient name, drug name, Dr. Name/signature Who should be contacted in the event that the pharmacist does not receive a cover script for an emerency verbal within 7 days of the oral C2 order? - correct answer- The dea What schedule is glutathione? - correct answer- C
What schedule is oxandrolone (Oxandrin)? - correct answer- C What schedule is phendimetrazine? - correct answer- C What schedule is be petaling (didrex)? - correct answer- C What schedule is Ephedrine? - correct answer- C According to federal law how much C5 containing opium can a Pharmacist sell within 48 hrs? - correct answer- Not more than 240mL/8oz. Or 48 dosage units According to federal law how much C5, other than opium containing, can be sold by a Pharmacist in 48 hrs? - correct answer- Not more than 120mL/4oz or 24 dosage units What are legal letters for the first letter in a prescriber's DEA number? - correct answer- A, B, F, G, M
The labeling requirements do not apply when no more than how many days supply of a C3 through 5 may be dispensed at one time for an institutionalized patient? - correct answer- 34 day supply or 100 dosage units Filing systems for prescription hard-copies? - correct answer- 2 file system - C2 in one drawer and C3 through non-controlled in another (C3-5 must be marked with a red C) 3 file system How long should prescription hard-copies be maintained? - correct answer- 5 years What is the purposes of drug product select? - correct answer- To provide for the drug product selection of equivalent drug products and promote the greatest possible use of such products What does Bioequivalent mean? - correct answer- Same dosage form of identical active ingredients in identical amounts
What does Chemically equivalent mean? - correct answer- Contain amounts of the identical therapeutically active ingredients in the identical strength, quantity, and dosage form and meet present compendial standards When can a RPh not product select? - correct answer- Patient or caregiver instructs not to, Prescriber specifies on phone or writes NDPS, DAW, or BMN How many times may a prescription be transferred? - correct answer- Once, unless they share a real-time online database Who can conduct controlled and non-controlled transfers? - correct answer- RPh or Intern When a prescriber writes "do not label" on the original written prescription, what isn't placed on the dispensing label? - correct answer- Drug name When a prescription is written for an animal which of the following should be on the label: (A) name of animal, (B) species of animal, (C) name of owner - correct answer- Species of animal and name of owner
What should be on the exterior of an e-kit box? - correct answer- "Emergencies only"; listings of drugs: name, strength, quantity, route, and expiration; name, address, and telephone of pharmacy What are the restrictions on the contents of an e-kit? - correct answer- Can not contain multi dose vials, no more than 10 CS drugs, and no more than 50 total drugs What information shall be on repackaged containers - correct answer- Manufacturer, lot #, drug name, strength, dosage form, NDC, route, and expiration on a typewritten label How often shall a e-kit be inspected by a RPh? - correct answer- Once every 30 days and after reported use (must be inspected by a pharmacist) How long shall record of inspection and delivery of e-kit be maintained? - correct answer- 5 years Who determines the contents of an E-kit? - correct answer- Supplying pharmacy and LTCF
How soon after the e-kit is opened, should the pharmacy be notified? - correct answer- Within 24 hours The licensee must notify the Department in writing by e-mail, fax, or postal within how much time of any change in environment which will adversely affect the potency, efficacy, safety, or security of the drugs, devices, or biological a in the pharmacy (accident, natural disaster, interruption in utility services)? - correct answer- 24 hours The pharmacy must establish and implement disaster preparedness plans and procedures that address: - correct answer- (1) How the pharmacy will provide storage of drugs at proper temp (2) how the pharmacy will provide disposal of drugs in quality affected (3) how the pharmacy will secure the drugs from the public (4) how the pharmacy will maintain patient and inventory records What drugs are allowed on a public health clinic's formulary? - correct answer- Contraception, STD, and vaginal infections
Institutions: prior to first fill and every 30 days Who dispenses PPI? - correct answer- Hospital pharmacy, LTCF, doctors Failure to distribute a PPI is considered? - correct answer- Misbranding Common drugs that require a medguide? - correct answer- Antidepressants (SSRI), ADHD, NSAIDs, Fluoroquinolones, Thiazolidinedions Who is required to dispense medguides? - correct answer- Dispensers to outpatients What Form or Program is used by healthcare providers and consumers for voluntary reporting of ADR - correct answer- FDA Form 3500 or MedWatch
Does a RPh have to be the one to make the "offer for counseling"? - correct answer- No, but it has to be verbally offered by a pharmacy staff member What act protects against intential contamination of OTCs? - correct answer- Federal Anti-Tampering Act 1982 Are OTC labels required to have Lot# and Exp date? - correct answer- No How long should a ephedrine, pseudoephedrine, phenylpropanolamin logbook be maintained? - correct answer- 2 years When doesn't a logbook or ID for the sale ephedrine need to be used? - correct answer- Single sales < 60mg Nebraska requires electronic transmission for the sale of methamphetamine precursor, what information is required? - correct answer- Name, age, address of the person purchasing; name and quantity of product; date and time of purchase; name/initials of seller; type and number of ID... Must be 18 to purchase or sell
